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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	1 April 2024
Main ID:	NCT02273284
Date of registration:	19/10/2014
Prospective Registration:	Yes
Primary sponsor:	Hamilton Health Sciences Corporation
Public title:	Pain Perception of Children and Youth Receiving Non-sedated Botulinum Toxin-A Injections Using the Buzzy®
Scientific title:	Pain Perception of Children and Youth Receiving Non-sedated Botulinum Toxin-A Injections Using the Buzzy®
Date of first enrolment:	December 2014
Target sample size:	23
Recruitment status:	Terminated
URL:	https://clinicaltrials.gov/ct2/show/NCT02273284
Study type:	Interventional
Study design:	Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: None (Open Label).
Phase:	N/A

Countries of recruitment
Canada

Contacts

Name:	Ronit Mesterman, M.D.
Address:
Telephone:
Email:
Affiliation:	McMaster University

Key inclusion & exclusion criteria

Inclusion Criteria:

- Any child and youth who receives non-sedated Botulinum toxin-A injections and is
interested and consenting to using the Buzzy

Exclusion Criteria:

- Patients receiving Botulinum Toxin-A injections under sedation

- Patients younger than 2 years or older than 18 years.

Age minimum: 2 Years
Age maximum: 18 Years
Gender: All

Health Condition(s) or Problem(s) studied

Pain

Intervention(s)

Device: Buzzy

Primary Outcome(s)

Faces Pain Scale revised [Time Frame: The participants will be asked to rate their pain 3 minutes after the treatment. This will take about 2-5 minutes.]

Secondary Outcome(s)

FLACC scale (after intervention) [Time Frame: Participants will be observed and rated on the FLACC scale 5 minutes after the intervention.]

Heart rate (after intervention) [Time Frame: The heart rate will be captured 5 minutes after the intervention.]

Heart rate (during intervention) [Time Frame: The heart rate will be captured during the intervention.]

Heart rate (baseline) [Time Frame: The heart rate will be captured 1 minute before the intervention]

FLACC scale (base line) [Time Frame: Baseline: Participants will be observed and rated on the FLACC scale 1 minute prior to the intervention.]

FLACC scale (during intervention) [Time Frame: Participants will be observed and rated on the FLACC scale during the intervention. Intervention time is typically 1-3 minutes.]

Secondary ID(s)

no number yet

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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